Scientist - Solid State
San Carlos (San Mateo County) Design / Civil engineering / Industrial engineering
Job description
Job Description
We are seeking a Scientist to support product development in the Early Inhaled Product Development Group at Novartis. This multidisciplinary team works with a global team to develop Novartis’ respiratory pipeline. The primary responsibilities of this group extend from preclinical development to early clinical development to technology transfer to our late-stage development group. While the focus is on product development, this group also conducts research and strives to publish papers/patents and present our work externally.
The candidate would be familiar with a number of techniques core to characterization of solid dosage forms (thermal analysis, X-ray diffraction, spectroscopy, vapor sorption, imaging, particle sizing, etc.), with deep experience in one or more of them. The person would use these and other techniques to characterize our materials and solve physical pharmacy problems, would work to extend our technology platforms, and would apply scientific principles and concepts to potential inventions. An understanding of solid-state form is essential, as the position routinely involves characterization of amorphous materials, polymorphs, hydrates/solvates, and, occasionally, cocrystals.
This person will primarily be responsible for facilitating formulation to enable fast-entry into human studies and to transfer technology to late-stage groups. By applying a science- and risk-based, phase-appropriate approach, the candidate will be integral to a team that formulates drugs for nonclinical studies as well as for all stages of clinical development. Depending on the breadth of experience, development opportunities, and departmental needs, the candidate may also be involved in: pre-formulation investigations, physical characterization method development and validation, and physical form screening and characterization. The candidate will be responsible for carrying out laboratory experiments as well as computational efforts related to their primary area of responsibility. The candidate will also be involved in writing technical reports and CMC sections of regulatory dossiers (INDs, IMPDs, NDAs, etc.). Technology development and innovation are an important element of this role, and the person will contribute to the development of invention disclosures and patent applications.
The successful candidate will represent the solid-state pharmaceutics function in multidisciplinary project teams across all stages of product development; she or he will need to work closely with team members in a collaborative fashion, providing recommendations and technical oversight to ensure that deliverables are met. The individual will need to work effectively with a variety of departments, customers, and partners, including CROs and peers at other Novartis sites.
The position will also involve management of one or more of our physical characterization laboratories. This includes instrument ownership (calibration, routine maintenance), management of vendors, and compliance with health and safety requirements (e.g., laboratory safety inspections). Furthermore, the candidate will work to plan for and identify near-term and long-term capital equipment needs to extend our capacity and analytical capabilities.
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Desired profile
Minimum requirements
A Ph.D. in Pharmaceutical Sciences or Chemical Engineering, or a B.S. degree in related fields with equivalent experience in the Pharmaceutical Industry is required. The candidate must have a solid scientific knowledge in Pharmaceutical Sciences, and a good understanding of the drug development process, including working in an FDA-regulated environment. Knowledge of current GMPs as they apply to laboratory practices is highly desired.
The candidate must be a subject-matter expert in solid-dosage formulation characterization. Scientific creativity and independent thought are essential to the role, as are excellent communication skills (written and oral) and interpersonal skills. The successful candidate must also have sound judgment and strong problem-solving skills, demonstrating the ability to plan, design, execute, and analyze laboratory experiments to advance projects and guide formulation and process development, leading to scalable manufacturing processes. A proven track record of publications in peer-reviewed journals is desirable.